MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. SPINAL HARDWARE; ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION

Model Number 50MM ROD

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 06/26/2023

Event Type  Injury  

Event Description

Implanted medtronic screw and rod in lumbar spine were both broken causing a scheduled return to the operating room for removal of hardware.Reference report: mw5118946.

• Brand Name: SPINAL HARDWARE
• Type of Device: ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC.
• MDR Report Key: 17227071
• MDR Text Key: 318275663
• Report Number: MW5118945
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 50MM ROD
• Device Catalogue Number: 1553201050
• Device Lot Number: 0776188W
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCREWS
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 106 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White